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临床试验/EUCTR2006-002499-16-DE
EUCTR2006-002499-16-DE进行中(未招募)不适用

Early Access of TMC125 in combination with other antiretrovirals in treatment-experienced HIV-1 infected subjects with limited treatment options.

Janssen R&D Ireland0 个研究点开始时间: 2006年8月29日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. Subject or Legal Authorized Representative has voluntarily given informed con-
  • sent before initiation of trial procedures.
  • 2. Subject has documented HIV-1 infection.
  • 3. Male or female subject over 18 years of age.
  • 4. Subject has limited treatment options due to virological failure or intolerance to
  • multiple ARV regimens.
  • 5. Subject is at least 3-class experienced (3 classes of licensed oral ARVs: N[t]RTIs,
  • PIs, NNRTIs).
  • Note: Subjects with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria.
  • 6. Subject has previously received 2 different PI-based regimens.
  • 7. Subject is unable to use currently approved NNRTIs due to resistance (primary or
  • acquired) and/or intolerance.
  • 8. Subject, if currently receiving an ARV regimen, is not achieving adequate virologic
  • suppression on his/her current regimen (defined as a confirmed detectable
  • plasma VL on the current treatment).
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. Primary HIV infection.
  • 2. Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).
  • 3. Any condition which, in the opinion of the investigator, could compromise the sub-
  • ject’s safety or adherence to the protocol.
  • 4. Use of disallowed concomitant therapy, including disallowed ARVs.
  • 5. Use of non-ARV investigational medications within the 30 days prior to baseline
  • 6. Use of investigational ARVs, unless stated as an exception in Section 5.3.8.2.2 of
  • the protocol.
  • 7. Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis,
  • acute viral infection) or findings during screening of medical history or physical
  • examination that is not either resolved or stabilized for at least 30 days before
  • the screening phase of the trial.
  • 8. Acute viral hepatitis, including but not restricted to A, B or C.
  • 9. Pregnant or breast-feeding female.
  • 10. Female subject of childbearing potential not using effective non-hormonal birth
  • control methods or not willing to continue practicing these birth control methods
  • from screening until the last trial related activity.
  • Note: Hormone based contraception may not be reliable when taking TMC125; therefore, to be eligible for this trial, women of childbearing potential who may have vaginal intercourse should either:
  • (1) Use a double barrier method to prevent pregnancy (i.e., use a condom without
  • spermicide, with either a diaphragm or cervical cap) or
  • (2) Use hormone based contraceptives in combination with a barrier contraceptive
  • (i.e., male condom without spermicide, diaphragm or cervical cap or female
  • (3) Use an intrauterine device (IUD) in combination with a barrier contraceptive (i.e.,
  • male condom without spermicide, diaphragm or cervical cap or female condom) or
  • Note: The use of an IUD has been associated with an increased rate of sexually
  • transmitted diseases.
  • (4) Be non-heterosexually active, practice sexual abstinence or have a vasectomized
  • partner (confirmed sterile).
  • Note: Women who are postmenopausal for at least 2 years, women with total
  • hysterectomy and women with tubal ligation are considered of nonchildbearing
  • 11. Subjects with the following laboratory abnormalities as defined by a standard-
  • ized grading scheme based on the Division of AIDS (DAIDS) grading table (up-
  • dated version from December 2004, see Section 7.2):
  • - Hemoglobin < 7,4 g/dL (4,5 mmol/L)
  • - Absolute neutrophil count < 500/mm³ (0,5 x 10 9/l)
  • - Platelets < 25 000/mm3 (25 000 x 10 9/l)
  • - Prothrombin time (PT) >1,5 x upper limit of laboratory normal range (ULN)
  • Note: Subjects on anticoagulant therapy with elevated PT > 1,5 ULN require approval of the sponsor prior to enrollment.
  • - Alkaline phosphatase > 5 x ULN
  • - Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 5 x ULN
  • - Bilirubin > 5 x ULN
  • Note: Subjects with elevated bilirubin > 5xULN assessed as related to a component
  • of ART therapy may be enrolled with prior approval of the sponsor.
  • - Lipase > 3 x ULN
  • - Amylase > 5 x ULN if lipase > 2 x ULN
  • - Creatinine > 1,8 x ULN
  • 12. Subjects with clinical or laboratory evidence of significantly decreased hepatic
  • function or decompensation, irrespective of liver enzyme levels.
  • Note: Subje

研究者

发起方
Janssen R&D Ireland

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